From gadgets and guns to medical devices

Features - COVER STORY

Northeast Laser & Electropolish transitioned from a tiny start-up in a well-defined niche to grow 70-fold in less than 25 years with teamwork, smart hiring, and strategic moves into technologies, services, and markets – such as its latest venture combining laser cutting with Swiss machining.

The journey started in 1993, when Rich Rosselli and Kurt England, two young engineers manufacturing blood analyzers and centrifuge products at DuPont, realized they shared the entrepreneurial bug. England had overseen DuPont’s transition from product marking using roll engraving or screen printing to the then-new process of laser engraving. He saw an opportunity for a laser-marking firm in Connecticut that could be more responsive to customer needs. The partners bought a laser from General Scanning and took the plunge.

“It was a tough sale,” Rosselli recalls. “Two guys and a laser trying to convince medical companies they should change what they were doing and go with us.”

Luckily, their ability to engrave promotional products and firearms found a receptive market, sustaining them for the first two years.

The right people, services

Success in the promotional products and firearms markets enabled NLE to buy an additional laser and to hire more people, launching them into larger industrial accounts. Among the key hires in the ’90s were Tom Hecht and John Franchi who became co-owners through sweat equity.

Hecht was doing quality control at DuPont and pushed NLE into automatic indexing and handling parts, “capabilities serving us well to this day,” Rosselli says.

Franchi joined as a sales engineer and was instrumental in guiding NLE into new opportunities, broadening NLE’s appeal beyond the immediate geographic area. Medical accounts, in particular, were unwilling to send parts any distance just to get laser marking. Franchi noted that many of these parts were electropolished right before laser marking and passivated immediately afterward. So NLE added those capabilities, expanding its marketability.

“At about the same time we took our now extensive laser knowledge and added laser welding,” Rosselli says. “This meant we could assemble, weld, electropolish, mark, and passivate, all within a few days. We had already established a company with a great focus on customers and rapid turnaround. We were using technology wherever we could to improve efficiency. But now people realized we had a really valuable combination of offerings and unique talents in handling parts.”

The big leagues

Co-founder and principal Rich Rosselli with a surgical guidewire.

Franchi brought an exciting opportunity in 2009: “One of the top 40 medical OEMs was building a single-use, outpatient, multi-component device in Costa Rica. The assembly required eleven welds, and every time a weld failed – which happened with some frequency – they had to throw out the entire lot of 300. Once we applied laser welding, the strength went up by a factor of two to three and the reject rate dropped to basically zero.”

Dave Hornak engineered a process that uses a vision system to automatically target the laser and a motion control system to make all the necessary gyrations to orient the part for the 11 welds. The operator simply loads the next part while the machine is welding.

This doubled their production rate, allowing them to price the job so competitively that they’ve been doing it for more than seven years with rising volumes.

“The customer originally thought that we would develop the process and then they’d take it in-house. But when they saw the six-station line we’d built here and the level of complexity involved, they decided it would be better to leave it with us. We now run lots of 3,000 using a fully validated process,” Franchi says.

Rosselli adds that Franchi, Hornak, and their team built and validated the entire line in three months, meeting the customer’s tight schedule. “In most companies this would have been a six-to-nine-month project.”

NLE has gone from a company that performed a few operations on other people’s components, to becoming a contract manufacturer that builds the entire assembly, solving a variety of customer challenges. This has earned them a place as a direct supplier to six of the top 40 medical OEMS and a Tier II supplier to most of the remainder. The latest step in this journey depended on yet more technology – the Tsugami LaserSwiss.

Investments pay off

While the contract manufacturing business grew, so did the complications and frustrations, especially when using outside suppliers. In one case, NLE delivered a welded assembly to a medical OEM but was dependent on an outside vendor to produce a key component. Producing that component required a chemical cutoff, wire EDM, a turning operation for an E-ring groove, and a centerless grind. NLE didn’t have those capabilities, and even its outside supplier had to send out the grinding work.

“Our customer was on us for quality, delivery, and pricing,” Rosselli remembers. “That’s when we called Mike Tierney of the Morris Group. He told us Tsugami/Rem Sales (a division of the Morris Group, Windsor, Connecticut) had a machine that could load 12ft bars of tubing stock and perform all the machining and laser cutting operations in one setup. All we had to do was weld it afterward.”

That machine is the Tsugami S205 LaserSwiss, which combines 5-axis Swiss machining with a fully integrated laser. This gave NLE the ability to apply up to 32 cutting tools in a variety of front, back, and side orientations with laser cutting at up to 20ips (500mm/sec).

“The Swiss-turn accuracy of the Tsugami met the required tolerances of the surfaces that were being ground, and the laser easily cut the slots and areas that were being EDM’d,” Franchi says. “We can do all the machining and laser cutting operations in the Tsugami, making us so efficient that we were able to sell the entire assembly to our customer for the price we were paying for one of the components. The net result was about a 40% cost reduction to the customer.”

Helping ensure success

NLE can laser mark a 2D matrix and change the surface to white when required.

“Mike recognized from the beginning that most Tsugami buyers have extensive machining experience and are ready to add another machine that has a laser as an additional tool. He knew that while we might have the laser knowledge, we needed to be brought up to speed on machining,” Rosselli notes.

First, the Tsugami/Rem Sales team helped by producing prototypes on the machine to test cycle times and quality. Based on that data, NLE lined up financing and made the investment. At that point, NLE hadn’t completed the required plant extension (now 31,000ft2 of production space, plus offices), so Morris offered to train Hornak and Eric Olander (a mechanical engineer and NLE’s first Tsugami operator) at their facility.

Rosselli says “Morris even programmed the initial process we’d use and selected the tools. And, any time we had issues, Morris had someone down here the same day or the next day – whatever it took.

Speeding time to market

The first success with the Tsugami immediately brought in more work.

“Our supplier rating went up dramatically and it opened other doors,” Rosselli explains. “And as those doors opened, customers brought us additional work for the Tsugami – so much so that we quickly realized we needed another one.”

Franchi cautions, “Just buying the Tsugami isn’t necessarily going to bring you business. In our case we’re using them for products that get other operations. Some parts come off the Tsugami and get a validated welding process. Others come out and get a very difficult laser marking. The Tsugami is part of our overall business strategy of providing our customers with multiple capabilities so they don’t have to deal with multiple vendors.”

Rosselli says, “Roughly half of what goes through here gets only one process, like only laser marking or only laser welding. While roughly half get two or more.”

On the other hand, lots of the one-operation jobs they get came from customers who hired them to do something else.

Franchi explains, “It’s very difficult to get on some of the OEM vendor lists. But once you’re on it you can bid for other items within your company’s capabilities. And one of the biggest things going on in medical today is time to market. Engineers often design parts that are difficult to manufacture, but a LaserSwiss gives the ability to apply all kinds of cutting technology to a problem.”

More than giving NLE an important aid in adapting to customer requirements and reducing part handling, the LaserSwiss is also just plain fast – 6x faster than standard cutting techniques.

NLE initially bought their second Tsugami for a whole new family of parts.

Franchi says they had looked at other machines that combined Swiss turning and laser cutting, but “there just wasn’t really any comparison. They’ve integrated the laser so well and the support we get from Morris is unbeatable. Their engineer was the first person to get us thinking about this technology. I wish I could tell you there was one deciding factor. But everything was better about the Tsugami.”

Rosselli’s conclusion? “It was a landslide; we made the right decision.”

LaserSwiss variations

In addition to the tsugami, S205 LaserSwiss, machine variants include a 6-axis version that offers 36 cutting tools, another that includes an additional B-axis for the laser head, and a model that includes a second laser head for welding. The machine uses a Fanuc control and includes a database of proven feeds, speeds, and power settings for commonly used materials. The 12ft bar feeder can deliver through-part coolant when cutting tubing, preventing damage to the backside of the tube and helping carry away material for a cleaner cut. While NLE hasn’t taken advantage of this capability, the LaserSwiss also has the ability to laser mark products using the annealing process.

Piezo linear motor

Departments - Motion, Design, Automation

The N-331 OEM walking motor drive is designed for high-end applications that require precision and durability.

The N-331 OEM walking motor drive is customizable and designed for high-end applications that require precision and durability.

Piezo motors do not create magnetic fields, nor are they influenced by magnetic or electric fields – an advantage to applications such as e-beam lithography and MRI technology. Other applications include optics, microscopy, automation technology, imaging technology, and medical engineering.

The units are available with 3 standard travel ranges from 25mm to 100mm in open and closed-loop configurations. They do not require maintenance or lubricants, are vacuum compatible, function in a wide temperature range, and are intrinsically wear-free.

Spring-engaged tooth brakes

The electromagnetic spring-engaged tooth brake (SETB) offers reliable, consistent operation within medical applications. The power-off brake features large bore sizes, low backlash, high torque-to-size ratio, many index positions, positive engagement, and a reliable coil with custom voltages. These features make it a choice for robotics, scanning equipment, and treatment tables.

Custom bore sizes are available and each brake is maintenance-free under proper operating conditions.

Making the connection

Features - Adhesives

Soft skin adhesives (SSAs) are non-sensitizing while remaining tacky and soft. SSAs retain bonding, even upon repositioning, maintaining tack and adhesion properties after several applications.

Demand is booming for wearable medical devices used in diagnosis, monitoring, and drug delivery, with the global market projected to reach $612 billion by 2024, according to a 2016 report by market research firm Grand View Research – (see medical infographic, pg. 8).

To achieve success, wearable device designers and manufacturers must deal with a daunting range of clinical and business issues. Two of these – promoting efficacy and gaining a competitive advantage – illustrate how silicone adhesives and elastomers contribute important benefits.

Comfort, ease

Soft skin adhesives (SSAs) conform to the body so people can maintain an active life style.

The efficacy of a wearable diagnostic or therapeutic device depends directly on patient compliance, which relies on comfort during wear and removal. Many designers are turning to silicone pressure-sensitive adhesives (PSAs) with stronger adhesion and soft skin adhesives (SSAs) featuring lower peel adhesion for delicate or fragile skin.

Silicone PSAs and SSAs deliver a more comfortable patient experience than competitive adhesive technologies, such as acrylics that can cause skin sensitization and polyurethanes that have very low breathability.

Another aspect of efficacy is ease of use, which promotes better results. For example, testing for sleep apnea typically requires an overnight session in a hospital or clinic because the complicated polysomnogram equipment must be operated by a professional technician. Home testing for sleep apnea, while it cannot diagnose as broad a range of disorders, has the advantage of enabling the patient to self-test under normal sleep conditions, which may deliver more-accurate results. Home tests, which combine a belt around the chest to measure respiratory effort, and a blood oxygen sensor and breath sensor attached to the nose with adhesive, are less cumbersome and allow patients to sleep in their preferred position.

In a related example, the ability to use a skin-adhered device when taking part in everyday activities, including sports and recreation, also supports efficacy. Several times more breathable than other organic polymers, the material also conforms well to body contours for improved fit and can be formulated with higher strength to accommodate body movements during vigorous sports activities.

Fetal monitoring devices provide peace of mind to mothers.

Competitive differentiation

Another factor in the success of a medical device is standing out from competitors. Differentiation may hinge on a superior design, higher performance, or a lower price. Material technology plays a big role in designing wearable medical devices that are well received in the marketplace.

Higher performance: Medical-grade silicones are biocompatible and have been used in medical device applications for 70 years. They are non-cytotoxic, non-irritating, and non-sensitizing to skin. Their mechanism of action combines low interfacial bonding for reduced impact on the skin with high flowability for stable adhesion via a mechanical interlock with skin pores. Silicones also spread easily to form films over the skin.

Silicone adhesives offer significant performance advantages compared to competitive adhesives. For example, although acrylic adhesives provide a strong, secure bond with the skin, they cannot be repositioned, and removal can cause pain and skin trauma in elderly or neonatal patients. Acrylic adhesives are also known to cause skin sensitization. Polyurethanes, which deliver medium adhesion, are more hydrophilic than silicones. Their moisture absorption can reduce adhesion to skin. These adhesives have very low breathability compared to silicones, and can leave a residue when removed.

Greater design freedom: With silicone technology, key properties such as adhesion level, conformity to the skin, peel strength, and permeability, transparency, and even processing parameters can be tailored to meet a medical device’s requirements.

Overmolding of silicone elastomers inclusive of adhesion components is a proven method for enhancing product design and consolidating parts. Instead of joining two components mechanically, overmolding provides a strong, enduring bond. A growing array of substrates suitable for overmolding with silicone elastomers offers designers new choices.

Silicones in wearables

Soft skin adhesives (SSAs) have low peel release force, which causes no damage to fragile or aged skin and minimizes pain to patients.

Identifying the best silicone adhesive or elastomer for a given application requires guidance from the silicone supplier regarding its chemistry (for example, solvent-based vs. solventless adhesive); performance properties such as tack, adhesion level, and dynamic shear; performance under different wear conditions; and, in the case of self-bonding elastomers, suitability for bonding with different plastic substrates.

The continued expansion of wearable technology is tied to a host of variables, including correct and compliant patient use and the ability of manufacturers to create products that can stand out in a highly competitive and fast-moving marketplace. Advanced silicone adhesives and elastomers play a key role by supporting efficacy and helping produce efficient, cost-effective, next-generation designs.

Adding other silicone technologies

Silicone adhesives not only support patient compliance, they can be used in combination with other silicone materials, such as elastomers, to deliver added performance to a medical device. One example is a new system used to prevent scar formation that leverages the elastic property of cross-linked silicone rubber to dynamically hold the sides of the incision together. Silicone adhesives avoid pulling and stabilize the skin.

Medical device manufacturing requires technology, solutions

Departments - Editor’s Letter

Cutting metal and making chips is not going away, but the industry continues to evolve.

Medical device manufacturing encompasses more than machining cobalt-chromium into knee replacement components or watching a parts catcher fill with precisely turned bone screws. Cutting metal and making chips is not going away, but the industry continues to evolve as technology rapidly changes the way things are done.

Case in point, just look at your cell phone. It’s fast, sleek, and the technology gives you so much functionality that you can’t imagine leaving home without it. That technology in your hand wasn’t nearly the same a quarter of a century ago. In the Fall of 1992, IBM and BellSouth unveiled ground-breaking technology – the Simon Personal Communicator – the first smartphone, although that term wasn’t used until 1995. After an unveiling in 1992, it went on sale in August 1994, offering touchscreen capability along with email and fax functions. And it was a clunky 8" x 2.5" x 1.5", weighing more than a pound. Simon survived six months on the market, roughly 50,000 units were sold, and then it became history – in 2014 one was featured in a display at the London Science Museum.

I never owned a Simon, but I did have the much more successful Palm Pilot, released in 1996 – mine spent more time in the desk drawer than in use – and taken off the market in 2011.

Just as the smart phone changed, manufacturing continues to evolve and those in the market must stay on top of technology to adapt, grow, and thrive. Companies must invest in technology that enables advanced manufacturing, remote monitoring, data collection, and preventive maintenance. Design engineers need to know what alternative materials, components, and adhesives are available that might work better, last longer, or be more antimicrobial. And contract manufacturers need to remain technologically savvy – testing, challenging, and embracing disruptive technologies – so the most advanced systems can be offered to customers.

As you read through this issue, take notice of the technology and manufacturing disrupters we feature this month:

Design engineers have expanded choices when developing products needing adhesives, and face more decisions on what end users want

Machine tool builders develop more advanced, hybrid equipment that can increase a facility’s capabilities in a smaller footprint

No matter what manufacturing services you offer, customers want to know products are being manufactured in the most cost-effective, efficient, advanced manner possible – the best end-to-end solution they can get.

~ Elizabeth

Hydromat Inc., Motch and Eichele form new company

Departments - Current Pulse

Hydromat-RE Inc., a new company specializing in the refurbishing, re-tooling, and selling of legacy Hydromat rotary transfer machines.

Hydromat Inc. and The Motch and Eichele Co. have joined together to create Hydromat-RE Inc., a new company specializing in the refurbishing, re-tooling, and selling of legacy Hydromat rotary transfer machines.

New Heimatec distributor

Okuma donates CNC machines to CPCC

Okuma America Corp. received Charlotte, North Carolina’s 2017 Mayor’s International Community Award (MICA) for a medium business for donating $100,000 in machine tools to the engineering technology programs at Central Piedmont Community College (CPCC). The gift enabled students to gain hands-on machining experience and the skills needed to enter the manufacturing workforce.

“The lack of skilled labor is one of the biggest threats to the U.S. manufacturing industry,” says Jim King, president and COO, Okuma America. “We’re honored to receive this award.”

Solar Atmospheres MedAccred for 3rd consecutive year

Solar Atmospheres officials announce that the company has been reaccredited with the MedAccred certification for heat treating at the Souderton, Pennsylvania, facility for a third consecutive year.

Solar Atmospheres in Souderton has held the MedAccred accreditation since the program’s inception in 2015. The company also was the first, globally, to achieve a MedAccred Heat Treating Accreditation, having maintained its accreditation seamlessly since the initial audit.